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Abbott Laboratories Recalls
156 recalls on record · June 27, 2012 to December 24, 2025 · Drugs, Food & Beverage, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 24, 2025Medical DevicesFDA
Abbott Laboratories recalls Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Hazard: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
November 19, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.
Hazard: Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
August 28, 2024Medical DevicesFDA
Abbott Laboratories recalls Alinity hq Analyzer, REF: 09P68-01
Hazard: 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts
April 10, 2024Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Hazard: The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
January 17, 2024Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000
Hazard: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
January 17, 2024Medical DevicesFDA
Abbott Laboratories recalls Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer al
Hazard: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
January 17, 2024Medical DevicesFDA
Abbott Laboratories recalls Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer
Hazard: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
January 3, 2024Medical DevicesFDA
Abbott Laboratories recalls Alinity ci-series System Control Module, REF: 03R70-01
Hazard: There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
December 27, 2023Medical DevicesFDA
Abbott Laboratories recalls Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number
Hazard: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
November 15, 2023Food & BeverageFDA
Abbott Laboratories recalls Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Hazard: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
April 19, 2023Food & BeverageFDA
Abbott Laboratories recalls Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
Hazard: Potential of foreign material (hard plastic) within product
January 25, 2023Medical DevicesFDA
Abbott Laboratories recalls Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Hazard: Reaction vessels may contain a potential contaminant that could affect their optical performance.
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 c
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as:
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
Hazard: Compromised seal integrity which could lead to spoilage
November 23, 2022Food & BeverageFDA
Abbott Laboratories recalls Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
Hazard: Compromised seal integrity which could lead to spoilage
September 7, 2022Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Hazard: One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.